Assessing Mucociliary Clearance and Airway Liquid Volume in the CF Airway

This study has been completed.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00248755
First received: November 2, 2005
Last updated: December 17, 2007
Last verified: December 2007
  Purpose

The objective of this study is to determine the effect of airway surface liquid (ASL) volume on mucociliary clearance in cystic fibrosis (CF). A two-isotope nuclear medicine technique will be utilized. This pilot trial will include the imaging of n=7 CF subjects and n=7 healthy subjects. The trial will include one study visit per subject that will take approximately 3 hours. Hypothesis: The simultaneous imaging of both a "floating" and a "penetrating" radioisotope tag will allow the relative effect of airway surface liquid volume on mucociliary clearance to be determined when evaluated in CF and normal subjects.


Condition Intervention
Cystic Fibrosis
Procedure: mucociliary clearance scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study of a New Technique for Assessing Mucociliary Clearance and Airway Surface Liquid Volume in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • radioisotope clearance rates-comparison between healthy and cf subjects

Estimated Enrollment: 14
Study Start Date: November 2005
Study Completion Date: August 2006
Detailed Description:

Improper function of the mucociliary clearance system in the Cystic Fibrosis (CF) lung is a major factor contributing to the chronic respiratory manifestations of the disease. Normally this host defense mechanism removes inhaled pathogens and toxins from the inner surfaces of the lung. In CF, mutations in the CF gene result in dysfunction of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) ion channel on the cells that line the airway epithelium, causing improper fluxes of ions such as sodium, chloride, and bicarbonate. The so called "low volume" hypothesis of CF pathogenesis contends that the liquid lining the airways becomes very thin and viscous due to abnormal absorption of sodium from the airways, which draws water out of the airways, partially or totally defeating mucociliary clearance. The rate at which the mucociliary system clears materials from the lungs can be quantified using a nuclear medicine test called a mucociliary clearance scan. This study pilots a new variation of the mucociliary clearance scan that uses both "floating" and "penetrating" radioisotope tags. The difference in clearance between these tags will provide information on how airway surface liquid volume affects mucociliary clearance. This pilot trial will include the imaging of n=5 CF subjects and n=5 healthy subjects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical symptoms (CF subjects only)
  • Clinically stable as determined by the investigator (pulmonologist)

Exclusion Criteria:

  • Reactive airways disease
  • Tobacco smokers
  • Positive urine pregnancy test on the day of testing
  • FEV1p value of < 30%
  • SaO2 < 92%, or if they require supplemental oxygen.
  • Subjects receiving other radioisotope treatments within the last 2 weeks will be excluded.
  • Normal subjects with any history of lung disease will be excluded.
  • Women currently breastfeeding an infant.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00248755

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Timothy E Corcoran, Ph.D. University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00248755     History of Changes
Other Study ID Numbers: CFFR883
Study First Received: November 2, 2005
Last Updated: December 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
cystic fibrosis
mucociliary clearance
nuclear medicine

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 01, 2014